Effectiveness of Telepsychiatry-based Culturally Sensitive Collaborative Treatment of Depressed Chinese Americans
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telepsychiatry-based Culturally Sensitive Collaborative Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Telepsychiatry, Culturally Sensitive Collaborative Treatment, Chinese Americans, Depression
Eligibility Criteria
Inclusion Criteria:
- Individuals with Chinese ethnicity, defined as people who self-identify as being Chinese based upon having either one or both parents being ethnic Chinese.
- Monolingual Chinese American immigrants, defined as people who require or prefer to be interviewed in Chinese (including Cantonese, Taiwanese, Mandarin, and Toisanese dialects).
- Men or women age 18 or older, who live in the greater Boston area.
- Individuals who are competent to consent and have completed a written consent form.
- Individuals who have a PCP.
- Patients who screen positive for MDD, current according to the fourth version of the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV) as diagnosed by the Mini International Neuropsychiatric Interview (MINI; Sheehan et al, 1998)
- Individuals who are willing to receive phone interviews for monitoring of symptoms and for additional support (care management) if available.
Exclusion Criteria:
- Patients with serious suicidal risk.
- Patients with unstable medical illnesses requiring imminent hospitalization or rendering patients unsuitable for clinical interview.
d. Patients with comorbid severe mental disorders including:
- Organic mental disorders.
- Alcohol or substance abuse disorders active within the last year.
- Schizophrenia.
- Delusional disorder.
- Psychotic disorders not elsewhere classified.
- Bipolar disorder. e. Patients with history of treatment by a psychiatrist in the past 4 months.
Sites / Locations
- South Cove Community Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
TCSCT
Usual Care
Arm Description
Outcomes
Primary Outcome Measures
Hamilton Rating Scale for Depression
Secondary Outcome Measures
Clinical Global Impressions (Severity of Depression and Global Improvement)
Full Information
NCT ID
NCT00854542
First Posted
February 27, 2009
Last Updated
November 30, 2016
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00854542
Brief Title
Effectiveness of Telepsychiatry-based Culturally Sensitive Collaborative Treatment of Depressed Chinese Americans
Official Title
Effectiveness of Telepsychiatry-based Culturally Sensitive Collaborative Treatment of Depressed Chinese Americans
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Hypothesis 1. Telepsychiatry consultations will be acceptable and well-received by depressed Chinese Americans and by their primary care clinicians.
Hypothesis 2. Depressed Chinese Americans in remote primary care clinics receiving T-CSCT will have improved outcomes compared to patients who receive Usual Care by primary care physicians.
Detailed Description
Telepsychiatry-based CSCT (T-CSCT):
Live and interactive Telepsychiatry (using videoconferencing) brings tremendous opportunities to clinical care, education, research, and administration. In the U.S. to date, telepsychiatry has been implemented in rural areas where people lack access to psychiatrists (Baer et al, 1997), in the Prison System with service users constrained from traveling (Brecht et al., 1996), in rural native American resettlement areas (Shore & Spero, 2005), and in Alaska where residents are faced with both distance and a shortage of mental health professionals. In this proposed study, we plan to investigate the effectiveness of telepsychiatry-based CSCT (T-CSCT) to provide culturally sensitive collaborative management of MDD to monolingual Chinese Americans. For this group of patients, telepsychiatry consultation could be a necessity both in urban as well as rural primary care clinics that are not staffed with bilingual psychiatrists. T-CSCT plans to utilize the advanced telemedicine technology in major academic centers to connect the scarce resource of bilingual and bicultural mental health professionals to underserved Chinese Americans to improve their access to treatment of MDD.
T-CSCT will explore the usefulness and effectiveness of recognizing MDD subjects through consumer-initiated depression self-screening using the validated CB-PHQ-9, which will be made available in community newspapers, journals, and on the internet. To facilitate care management for Chinese Americans, a Depression Toolkit for Chinese Americans will be developed, which will include information on the nature and treatment of MDD, the CB-PHQ-9 for depression self-screening, a bilingual instrument to monitor progress of depressive symptoms, strategies for patients to negotiate with health professionals for individually tailored treatment for depression, and answers to frequently asked questions (FAQs) by Asian American immigrants on MDD and its treatment. If shown to be effective, the T-CSCT can be the prototype of a telemedicine-based Multiracial Mental Health Resource Center to provide services to other minority populations to reduce disparities in mental health treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Telepsychiatry, Culturally Sensitive Collaborative Treatment, Chinese Americans, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
241 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TCSCT
Arm Type
Active Comparator
Arm Title
Usual Care
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Telepsychiatry-based Culturally Sensitive Collaborative Treatment
Intervention Description
T-CSCT: Patients in Group A will receive T-CSCT, which consists of Telepsychiatry-based Culturally Sensitive Psychiatry Assessment using the Engagement Interview Protocol (EIP) plus Care Management.
Primary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression
Time Frame
Screen, Week 9, 17, 24
Secondary Outcome Measure Information:
Title
Clinical Global Impressions (Severity of Depression and Global Improvement)
Time Frame
Screen, Week 9, 17, 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Individuals with Chinese ethnicity, defined as people who self-identify as being Chinese based upon having either one or both parents being ethnic Chinese.
Monolingual Chinese American immigrants, defined as people who require or prefer to be interviewed in Chinese (including Cantonese, Taiwanese, Mandarin, and Toisanese dialects).
Men or women age 18 or older, who live in the greater Boston area.
Individuals who are competent to consent and have completed a written consent form.
Individuals who have a PCP.
Patients who screen positive for MDD, current according to the fourth version of the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV) as diagnosed by the Mini International Neuropsychiatric Interview (MINI; Sheehan et al, 1998)
Individuals who are willing to receive phone interviews for monitoring of symptoms and for additional support (care management) if available.
Exclusion Criteria:
Patients with serious suicidal risk.
Patients with unstable medical illnesses requiring imminent hospitalization or rendering patients unsuitable for clinical interview.
d. Patients with comorbid severe mental disorders including:
Organic mental disorders.
Alcohol or substance abuse disorders active within the last year.
Schizophrenia.
Delusional disorder.
Psychotic disorders not elsewhere classified.
Bipolar disorder. e. Patients with history of treatment by a psychiatrist in the past 4 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Yeung, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Cove Community Health Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27631145
Citation
Chen JA, Shapero BG, Trinh NT, Chang TE, Parkin S, Alpert JE, Fava M, Yeung AS. Association Between Stigma and Depression Outcomes Among Chinese Immigrants in a Primary Care Setting. J Clin Psychiatry. 2016 Oct;77(10):e1287-e1292. doi: 10.4088/JCP.15m10225.
Results Reference
derived
PubMed Identifier
27561153
Citation
Yeung A, Martinson MA, Baer L, Chen J, Clain A, Williams A, Chang TE, Trinh NH, Alpert JE, Fava M. The Effectiveness of Telepsychiatry-Based Culturally Sensitive Collaborative Treatment for Depressed Chinese American Immigrants: A Randomized Controlled Trial. J Clin Psychiatry. 2016 Aug;77(8):e996-e1002. doi: 10.4088/JCP.15m09952.
Results Reference
derived
PubMed Identifier
21943315
Citation
Yeung A, Hails K, Chang T, Trinh NH, Fava M. A study of the effectiveness of telepsychiatry-based culturally sensitive collaborative treatment of depressed Chinese Americans. BMC Psychiatry. 2011 Sep 26;11:154. doi: 10.1186/1471-244X-11-154.
Results Reference
derived
Learn more about this trial
Effectiveness of Telepsychiatry-based Culturally Sensitive Collaborative Treatment of Depressed Chinese Americans
We'll reach out to this number within 24 hrs